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Anti-tumor antibiotic

Debio 4228 for Prostate Cancer

Phase 2
Recruiting
Research Sponsored by Debiopharm International SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Participant with histologically confirmed locally advanced/metastatic prostate cancer
Must not have
Indication for androgen deprivation combination therapy
Major surgery within 4 weeks before the start of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cohorts 1 and 2: post-dose on day 84; cohort 3: post-dose on days 84 and 168
Awards & highlights

Summary

This trial aims to understand how the drug Debio 4228 moves through and affects the body.

Who is the study for?
This trial is for men with advanced or metastatic prostate cancer who are candidates for ongoing hormone therapy. They should have a life expectancy of at least 6 months, be relatively active (ECOG status 0-2), and have normal organ function. Specific medical criteria must also be met.Check my eligibility
What is being tested?
The study is testing Debio 4228 to understand how it's processed in the body (pharmacokinetics) and its effects on the body's biological processes (pharmacodynamics) in patients with advanced prostate cancer.See study design
What are the potential side effects?
While specific side effects of Debio 4228 aren't listed, common ones for similar treatments include fatigue, hot flashes, decreased libido, gastrointestinal issues, and potential impacts on bone density.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to get out of my bed or chair and move around.
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My prostate cancer is advanced and has spread beyond the prostate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need hormone therapy for my cancer.
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I have not had major surgery in the last 4 weeks.
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I have had surgery to remove both testicles, adrenal glands, or pituitary gland.
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I have not had cancer in the last 2 years, except for prostate or certain skin cancers.
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I had chemotherapy or cryotherapy for prostate cancer within the last 8 weeks.
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I have heart problems or diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cohorts 1 and 2: post-dose on day 84; cohort 3: post-dose on days 84 and 168
This trial's timeline: 3 weeks for screening, Varies for treatment, and cohorts 1 and 2: post-dose on day 84; cohort 3: post-dose on days 84 and 168 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Concentration-time Curve of Debio 4228 Over 12 weeks (AUC84d)
Maximum Plasma Concentration (Cmax) of Debio 4228
Plasma Concentration of Debio 4228 at Week 12 (C84d)
+1 more
Secondary outcome measures
Change From Baseline in Serum Follicle-Stimulating Hormone (FSH) Over Time
Change From Baseline of Serum Luteinizing Hormone (LH) Over Time
Number of Participants With Clinically Significant Abnormalities in Laboratory, Vital Signs, and Electrocardiogram (ECG) Parameters
+8 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
If any alternative dose is deemed necessary based on preliminary data, participants may be enrolled in Cohort 3 to receive Debio 4228 loading dose IM, on Day 1 followed by a maintenance dose IM, 12 weeks after receiving the loading dose (Day 85).
Group II: Cohort 2: Debio 4228 Dose Level 2Experimental Treatment1 Intervention
Participants will receive a single IM administration of dose level 2 Debio 4228 on Day 1.
Group III: Cohort 1: Debio 4228 Dose Level 1Experimental Treatment1 Intervention
Participants will receive a single intramuscular (IM) administration of dose level 1 Debio 4228 on Day 1.

Find a Location

Who is running the clinical trial?

Debiopharm International SALead Sponsor
51 Previous Clinical Trials
7,205 Total Patients Enrolled
1 Trials studying Prostate Cancer
120 Patients Enrolled for Prostate Cancer
~40 spots leftby Mar 2026